Application 020178

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	Yes	Yes
002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/ML	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0160	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0162	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0164	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0166	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0182	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0186	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0192	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0196	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-9151	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9151	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9151	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9151	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72823	SUPPL	2022-12-08
61765	SUPPL	2020-02-04
58968	SUPPL	2019-06-04
58893	SUPPL	2019-05-30
34341	SUPPL	2015-11-25
21257	SUPPL	2015-11-24

Application 020178

Related Records#

Application Products#

NDC Listings For This Application#

Documents#